In the context of regulatory affairs, what does NDA stand for?

The term NDA stands for New Drug Application, which is a critical regulatory submission that pharmaceutical companies must file with regulatory authorities, such as the U.S. Food and Drug Administration (FDA), to seek approval to market a new drug. This comprehensive document includes data from clinical trials, proposed labeling, safety and efficacy information, and details about manufacturing processes. The review of the NDA is essential for ensuring that a new drug is safe and effective for public use before it can be marketed.

Understanding the NDA process is fundamental in regulatory affairs as it represents a major milestone in drug development. A successful NDA enables the transition of a product from development to commercialization, impacting not just the company that developed the drug, but also public health and safety.